Immune-related Adverse EventNCT06702566
The Effect of Serum Ferritin in irAE
A study testing PD-1 and PD-L1 inhibitor, Targeted drugs and chemotherapy drugs in people with Immune-related Adverse Event and Malignant Solid Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune-related Adverse Event, Malignant Solid Tumors, Acute Leukemia
- What is being tested?
- PD-1 and PD-L1 inhibitor, Targeted drugs and chemotherapy drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patient who meet all the following conditions can be selected for this trial:
- Patients voluntarily sign informed consent;
- The age was 18-75 years old, and the gender was not limited;
- Patients with definitive diagnosis of malignant solid tumor or acute leukemia;
- Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy.
- The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;
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- Sufficient bone marrow reserve at screening, defined as:
- Neutrophil absolute value (ANC) > 1.5 × 10^9/L；
- Lymphocyte absolute value (ALC) ≥ 0.3 × 10^9/L；
- Platelet (PLT) ≥ 100 × 10^9/L；
- Hemoglobin (HGB) ≥ 100g / L;
- The screening has appropriate organ function and meets the following criteria:
- Aspartate aminotransferase (AST) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
- Alanine aminotransferase (ALT) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
- Total serum bilirubin ≤ 1.5 times ULN (due to tumor infiltration ≤ 3 times ULN);
- Serum creatinine (SCR) ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60ml / min;
- Have the lowest level of lung reserve, defined as ≤ grade 1 dyspnea and oxygen saturation > 91% in non oxygen breathing state;
- International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial prothrombin time (APTT) ≤ 1.5 times ULN;
- The urine pregnancy test of women of childbearing age is negative. Any male and female patient with fertility must agree to use effective contraceptive methods during the whole study and at least 1 year after the study treatment.
Who cannot join
- Patient who meet any of the following conditions well excluded in this trial:
- Active systemic autoimmune disease is known before screening and is under treatment;
- Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；
- Those who have received organ / tissue transplantation before screening;
- Those who meet any of the following conditions during screening:
- positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg);
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- hepatitis B e antibody (HBE AB) and / or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit;
- positive for hepatitis C antibody (HCV AB);
- positive anti Treponema pallidum antibody (TP AB);
- HIV antibody test positive;
- the copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit;
- The heart meets any of the following conditions during screening:
- left ventricular ejection fraction (LVEF) ≤ 50% (echo);
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- hypertension (systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension that has not been controlled by standard treatment;
- have had myocardial infarction or cardiac surgery within 12 months before cell transfusion;
- clinically significant valvular disease.
- There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;
- Patients with active bleeding during screening;
- Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;
- Those who received live vaccine within 6 weeks before screening;
- Patients with active infection and need treatment during screening;
- Poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Liang Liu, MD., 86-22-23340123 ext. 3172, liangcoh@163.com
Xiubao Ren, MD. PhD., 86-22-23340123 ext. 3173, renxiubao@tjmuch.com
About this study
Official title: The Significance of Serum Ferritin in the Diagnosis, Differential Diagnosis, and Prognosis of Immune-related Adverse Event (irAE)
This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).
Read the detailed description
A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy). All patients received blood biochemistry and imaging at baseline, and adverse events were monitored. If a patient in the immunotherapy group presents with an AE, the AE is diagnosed by a multi-disciplinary MDT team including oncologists, rheumatologists, immunologists, respiratory pathologists, radiologists, and pathologists, and further diagnosed as irAE or non-irAE. All patients underwent hematologic testing every 3 days (at least 3 times) after the onset of AE including: blood routine examination, ferritin, CRP, D-dimer, and cytokines (IL-1β, IL-6, and TNF-α)until recovery from AE. Patients without AE will re-testing of baseline blood biochemistry every 4 treatment cycles.
- Being tested
- PD-1 and PD-L1 inhibitor, Targeted drugs, chemotherapy drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 and PD-L1 inhibitorDrug
PD-1 inhibitor includes pembrolizumab，Nivolumab，Sintilimab，tislelizumab，Triplimab，Camrelizumab, Serplulimab.
PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab.
Targeted drugsDrug
Targeted drugs includes EGFR-TKIs,ALK-TKIs,Multitargeted Tyrosine Kinase Inhibitors, VEGF antibody, EGFR antibody, antibody-drug conjugates drugs
chemotherapy drugsDrug
Chemotherapy drugs are determined based on the investigator's decision.
| Study group | Role | What they receive |
|---|---|---|
| A: Serum ferritin in patients receiving immunotherapy | Experimental | Patients will receive standardized anti-tumor therapy including immunotherapy according to clinical guidelines. Patients who treated with immuno-monotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy will be recruit in to test the serum ferritin level Receives: Drug: PD-1 and PD-L1 inhibitor; Drug: Targeted drugs; Drug: chemotherapy drugs |
| B: Serum ferritin in patients receiving targeted therapy | Active comparator | Patients will receive standardized anti-tumor therapy including targeted therapy according to clinical guidelines. Patients who treated with targeted monotherapy, or targeted plus chemotherapy will be recruit in to test the serum ferritin level Receives: Drug: Targeted drugs; Drug: chemotherapy drugs |
| C: Serum ferritin in patients receiving chemotherapy | Active comparator | Patients will receive standardized anti-tumor therapy including chemotherapy according to clinical guidelines. Patients who treated with chemotherapy will be recruit in to test the serum ferritin level Receives: Drug: chemotherapy drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculated cut-off value for serum ferritin in the diagnosis of irAE
Measured: 1 year
Determining the sensitivity and specificity of serum ferritin in the diagnosis of irAE
Measured: 1 year
Determining baseline level of serum ferritin predicts irAE occurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start4 Jul 2024
- Primary completion16 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE). A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy).
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiubao Ren, M.D, Ph.D, Principal investigator, ianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702566
- Sponsor's protocol ID
- E20240619
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Serum Ferritin in the Diagnosis, Differential Diagnosis, and Prognosis of Immune-related Adverse Event (irAE)
- ClinicalTrials.gov ID
- NCT06702566
- Acronym / sponsor ID
- E20240619
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).
Detailed description
A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy). All patients received blood biochemistry and imaging at baseline, and adverse events were monitored. If a patient in the immunotherapy group presents with an AE, the AE is diagnosed by a multi-disciplinary MDT team including oncologists, rheumatologists, immunologists, respiratory pathologists, radiologists, and pathologists, and further diagnosed as irAE or non-irAE. All patients underwent hematologic testing every 3 days (at least 3 times) after the onset of AE including: blood routine examination, ferritin, CRP, D-dimer, and cytokines (IL-1β, IL-6, and TNF-α)until recovery from AE. Patients without AE will re-testing of baseline blood biochemistry every 4 treatment cycles.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE). A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy).
| Arm | Type | Receives |
|---|---|---|
| A: Serum ferritin in patients receiving immunotherapy | Experimental | Drug: PD-1 and PD-L1 inhibitor, Drug: Targeted drugs, Drug: chemotherapy drugsPatients will receive standardized anti-tumor therapy including immunotherapy according to clinical guidelines. Patients who treated with immuno-monotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy will be recruit in to test the serum ferritin level |
| B: Serum ferritin in patients receiving targeted therapy | Active comparator | Drug: Targeted drugs, Drug: chemotherapy drugsPatients will receive standardized anti-tumor therapy including targeted therapy according to clinical guidelines. Patients who treated with targeted monotherapy, or targeted plus chemotherapy will be recruit in to test the serum ferritin level |
| C: Serum ferritin in patients receiving chemotherapy | Active comparator | Drug: chemotherapy drugsPatients will receive standardized anti-tumor therapy including chemotherapy according to clinical guidelines. Patients who treated with chemotherapy will be recruit in to test the serum ferritin level |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients voluntarily sign informed consent;
- The age was 18-75 years old, and the gender was not limited;
- Patients with definitive diagnosis of malignant solid tumor or acute leukemia;
- Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy.
- The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;
Key exclusion criteria (23 listed)
- Active systemic autoimmune disease is known before screening and is under treatment;
- Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；
- Those who have received organ / tissue transplantation before screening;
- Those who meet any of the following conditions during screening:
- The heart meets any of the following conditions during screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 and PD-L1 inhibitorPD-1 inhibitor includes pembrolizumab，Nivolumab，Sintilimab，tislelizumab，Triplimab，Camrelizumab, Serplulimab. PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab. | Drug | A: Serum ferritin in patients receiving immunotherapy |
| Targeted drugsTargeted drugs includes EGFR-TKIs,ALK-TKIs,Multitargeted Tyrosine Kinase Inhibitors, VEGF antibody, EGFR antibody, antibody-drug conjugates drugs | Drug | A: Serum ferritin in patients receiving immunotherapy, B: Serum ferritin in patients receiving targeted therapy |
| chemotherapy drugsChemotherapy drugs are determined based on the investigator's decision. | Drug | A: Serum ferritin in patients receiving immunotherapy, B: Serum ferritin in patients receiving targeted therapy, C: Serum ferritin in patients receiving chemotherapy |
Primary outcome
calculated cut-off value for serum ferritin in the diagnosis of irAE
Time frame: 1 year
Determining the sensitivity and specificity of serum ferritin in the diagnosis of irAE
Time frame: 1 year
Determining baseline level of serum ferritin predicts irAE occurrence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiubao Ren, M.D, Ph.D principal investigator
ianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD-1 and PD-L1 inhibitor, Targeted drugs and chemotherapy drugs in people with Immune-related Adverse Event and Malignant Solid Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Liu, M.D (86-22-23340123 ext. 3172, liuliang@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calculated cut-off value for serum ferritin in the diagnosis of irAE (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.